AcoArt III / Arterio-venous Fistula in China

Arteriovenous Fistula Stenosis Clinical Trial

Official title:

Drug-eluting Balloon for Arteriovenous Fistula in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366727
• Other study ID #: Acotec-05
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: July 7, 2022

Study information

• Verified date: July 2022
• Source: Acotec Scientific Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.

Description:

For years, first-line treatment of AVFs stenoses has been percutaneous transluminal angioplasty. However, restenosis and reintervention rates remain incredibly high and occur, according to recent studies, in up to 60% and 70% of patients at 6 and 12 months, respectively. Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia and drug-coated balloons,therefore, it represents an attractive option for AVF stenoses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: July 7, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age during 18-85 years old

• Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions

• Venous stenosis of the AV fistula

• target lesion has stenosis =50% evidenced by angiography. and have at least one symptom of these:1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow

• the length of target lesion =100mm

• Patient able to give informed consent

• residual stenosis =30% after predilation

Exclusion Criteria:

• Women who are breastfeeding, pregnant or are intending to become pregnant

• AVF located at lower limbs

• two or more than two stenosis at the target vessel.

• Obstruction of central venous return

• ISR

• AVF with acute thrombosis requiring lysis or thrombectomy in 30 days

• vascular access has surgery in 30 days or intending to undergo a surgery

• known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.

• Patients undergoing immunotherapy or suspected / confirmed vasculitis

• Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura

• Vascular access infection or systemic active infection

• patients's life expectancy is less than 12 months

• Renal transplantation has been planned or converted to peritoneal dialysis

• Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program

• involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Stenosis
• Fistula

Intervention

Device:
• drug-coated balloon catheter (Orchid, Acotec)
After predilation, using drug-coated balloon catheter to cover the whole treated segment
• plain balloon catheter (Admiral, medtronic)
After predilation, using plain balloon catheter to cover the whole treated segment

Locations

Country	Name	City	State
China	Beijing Friendship Hospital,Capital Medical University	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Tongren hospital, Capital medical university	Beijing	Beijing
China	The first hospital of Jilin medical university	Changchun	Jilin
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Guangdong provincial people's hospital	Guangzhou	Guangdong
China	Nanfang hospital	Guangzhou	Guangzhou
China	Shaoyifu hospital, zhejiang medical universiyt	Hangzhou	Zhejiang
China	Zhejiang provincial people's hospital	Hangzhou	Zhejiang
China	The first hospital of Chinese medical university	Harbin	Heilongjiang
China	Renji Hospital ShangHai Jiaotong University School Of Medicine	Shanghai	Shanghai
China	The first hospital of Hebei medical university	Shijiangzhuang	Hebei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Acotec Scientific Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary patency of target lesion in 6 months	Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention;2)thrombus formation in target lesion; 3) surgical removal of target lesion;4) AVF was abandoned because of the target lesion could not be retreated	6 months
Secondary	primary patency of target lesion in 12 months	Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention;2)thrombus formation in target lesion; 3) surgical removal of target lesion;4) AVF was abandoned because of the target lesion could not be retreated	12 months
Secondary	number of reinterventions	number of reinterventions in 12 months	12 months
Secondary	device success	Successful delivery to the target lesion, deployment, and retrieval at index procedure	during the procedure
Secondary	clinical success	The resumption of dialysis for at least one session after the index procedure	5 days
Secondary	Procedural Success	residual stenosis=30% and absence of SAE during perioperative period	2 weeks